Senior Clinical Scientist

This is a fully remote position, open to applicants in United States.

📋 Description

• Offer scientific and writing assistance for clinical strategy, clinical trial development, data analysis and visualization, and dissemination of clinical data.

• Perform critical reviews of both internally and externally facing documents.

• Collaborate with regulatory and commercial teams, key opinion leaders (KOLs), physicians, and clinical personnel.

• Contribute to the development of evidence and strategies for clinical research.

• Design study options and clinical endpoints to aid in decision-making processes.

• Utilize relevant literature and information sources to support the selection of clinical endpoints, performance goals, and methods for data collection.

• Work alongside Clinical Affairs to evaluate the budgetary and timeline implications of clinical trial options.

• Aid in the successful implementation of clinical trials, including the review of trial materials and providing scientific support as needed.

• Independently contribute to the clinical sections of Clinical Evaluation Reports.

• Conduct literature searches and maintain an up-to-date literature library.

• Write, format, and submit scientific publications.

• Create data visualizations, charts, posters, and presentations.

• Organize submissions to scientific meetings and other venues.

• Facilitate KOL interactions, advisory board meetings, medical conferences, and other events.

• Keep current with scientific and clinical knowledge in relevant therapeutic areas.

• Engage in the design of Investigator-Initiated Trials (IIT).

⛳️ Requirements

• A Bachelor’s degree in Life Sciences, engineering, statistics, or a related discipline is required.

• An advanced degree (MS, PhD, MD) is preferred.

• At least 12 years of experience in clinical research with a focus on managing clinical science/research activities.

• Experience in the medical device sector is essential.

• Background in oncology clinical trials is preferred.

• Experience in authoring and reviewing clinical documentation.

• Familiarity with GCP, ICH, and FDA guidelines and regulations pertaining to clinical trials.

• Proficient in analyzing data and preparing summaries tailored to various audiences.

• Preferred proficiency with standard statistical software packages such as SAS, R, SPSS, or MiniTab.

• Strong analytical capabilities for understanding and interpreting scientific research and literature.

• Adequate technical and disease-area knowledge to engage confidently with internal and external stakeholders.

• Exceptional writing and presentation abilities.

• Capability to manage multiple projects concurrently.

• Strong organizational, prioritization, and time management skills.

• Ability to accomplish tasks independently and efficiently while paying attention to detail.

• Must be eligible to work in the United States.

🏝️ Benefits

• Medical coverage.

• Dental coverage.

• Vision coverage.

• Life insurance.

• Short- and long-term disability protection.

• 401(k) plan.

• Flexible paid time off.